Inspections, Compliance, Enforcement, and Criminal Investigations
Can Tho Animal Fishery Products 23-Aug-02
Department of Health and Human Services
Public Health Service
College Park, MD 20740
August 23, 2002
Mr. Nguyen Van Kich
Can Tho Animal Fishery Products
Processing Export (CAFATEX)
Km 2081-Nation Road No. I
Chau Thanh District
Can Tho, Vietnam
Dear Mr. Kich,
The United States Food and Drug Administration (FDA) conducted an inspection of your firm on May 15th and 16th, 2002 and found that you have a serious deviation from the Seafood HACCP regulations which can be found in Part 123 of Title 21 of the Code of Federal Regulations (21 CFR Part 123). This deviation, which was previously brought to your attention during the inspection, causes your IQF cooked shrimp to be in violation of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. You can find this Act and the Seafood HACCP regulations through links in FDA's home page at www.fda.gov. The third edition of the Fish and Fisheries Products Hazards and Controls Guidance, which we also recommend that you use as a reference, can also be found on-line at: http://www.cfsan.fda.gov/~comm/haccp4.html
The deviation is as follows:
You must have a HACCP plan that lists verification procedures and frequencies of these procedures for each critical control point, in accordance with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for IQF cooked shrimp lists a monitoring frequency at the cook Critical Control Point that is not sufficient to ensure that your Critical Limits are met.
FDA recommends monitoring the temperature of the cook frequently enough to ensure that each item receives sufficient cook to prevent the growth of the target organisms. Monitoring the cook temperature no more than once every 20 minutes is not sufficient to assure that each batch of shrimp that enters the cooker receives the proper temperature for the prescribed time.
Please respond in writing within six (6) weeks from your receipt of this letter. Your response should outline the specific things you are doing to correct this deviation. Your response should include documentation such as a revised HACCP plan, completed monitoring records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will complete the corrective action. Failure to provide us evidence of corrections to the deviation may result in imports of your products being placed on "Detention Without Physical Examination" without further notice to you.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the U.S. Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Brian S. Landesberg, Consumer Safety Officer, Division of Enforcement, Office of Field Programs, HFS-606, 5100 Paint Branch Parkway, College Park, MD 20740. If you have questions regarding any issue in this letter, please contact Mr. Landesberg at 301-436-1622.
Judith A. Gushee
Division of Enforcement and Programs
Office of Field Programs
Center for Food Safety and Applied Nutrition